Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer

AGC Biologics

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer Metastatic Recurrent

Treatments

Drug: NGR-hTNF

Drug: doxorubicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00484432

NGR012

2007-000004-33 (EudraCT Number)

Details and patient eligibility

About

The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Full description

This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.

Enrollment

37 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients ≥18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered
Rechallenge with platinum regimens
No previous exposure to anthracyclines
Histologically or cytologically confirmed ovarian carcinoma
Life expectancy more than 3 months
ECOG Performance status 0 - 1
Normal cardiac function (LVEF ≥55%) and absence of uncontrolled hypertension
Measurable disease defined as ≥1 unidimensional measurable lesion ≥ 20 mm by conventional technics or ≥ 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis
Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
- Bilirubin < 1.5 x ULN
- AST and/or ALT < 2.5 x ULN in absence of liver metastasis
- AST and/or ALT < 5 x ULN in presence of liver metastasis
- Serum creatinine < 1.5 x ULN
Patients may have had prior therapy providing the following conditions are met:
- Chemotherapy and radiotherapy: wash-out period of 28 days
- Surgery: wash-out period of 14 days
Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
Patients must give written informed consent to participate in the study

Exclusion criteria

Concurrent anticancer therapy
Patients must not receive any other investigational agents while on study
New York Heart Association class II-IV cardiac disease
Acute angina
Patients with myocardial infarction within the last six (6) months
Patient with significant peripheral vascular disease
Thrombosis of main portal vein
Clinical signs of CNS involvement
Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Pregnancy or lactation. Patients with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.